With exceptional deliverability, an ultra-low tip profile, and unparalleled expansion range, it offers complete support for vessels of any size and complexity. To assess the safety and effectiveness of the Venovo Venous Stent xn0sLVcJO+VjiP gI(mB"#1ryrd OIt\>'"[dUCWe}"p@c UE|0a\ @4P#F4z|Cy:"!Cz}f2@3@p&qo)sI ?CdZ'PsnW3TTr_axHn! Find products, medical specialty information, and education opportunities. The C-Code used for NC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Do not resterilize and/or reuse the device. Patients having an enterography will have been given fasting and preparation instructions for prior to arrival. Safety Topic / Subject PMT Halo System with Carbon Graphite Open Back Ring and Titanium Skull Pins PMT Corporation Chanhassen, M. 3: . Premarket Submission Number Not Available/Not Released. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. For both in-person and virtual visits, BMC is here to ensure you have everything you need to make your visit a success. Bench test results may not necessarily be indicative of clinical performance. MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the . Patients having an enterography, may be at BMC up to 3 hours. Primary Patency by Kaplan-Meier estimates at 36 months are 84.0% for the total population (N=170), 74.8% for subjects with post-thrombotic syndrome (N=93) and 95.5% for subjects with non-thrombotic iliac vein lesions. Testing completed on 2.5 x 15 mm Emerge product (n = 18) and 2.5 x 20 mm Apex product (n = 14). Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. alcohol or nitroglycerine, stem cells, etc.) Every exam is interpreted by a radiologist with specialty expertise in the specific area of the body being imaged. During system flushing, observe that saline exits at the catheter tip. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. Boston, MA 02118 The Venovo Venous Stent System is supplied sterile and is intended for single use only. PDF Resolute Onyx Zotarolimus-Eluting Coronary Stent System Rapid Exchange Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. 2=[DE8m|E23 jIrL|bW30+;$12r+e5Jl+]pVIn[Ndck0xc$VVq+9e'0")m275ahsk8/` $4,,:8X3@$3h` u40y@p ` i;+:dXf`6@,ohH=`)35^7;7>n`pRwg 1hQb`br&Y' 6G 98 subjects x-rays were analyzed and no stent fractures were reported. Reproduced with Permission from the GMDN Agency. The Venovo Venous Stent System is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. EMERGE PTCA Dilatation Catheter - Boston Scientific We use cookies and other tools to enhance your experience on our website and to analyze our web traffic. Many exams involve IV contrast, which helps highlight the tissues and give the radiologist different information about an area(s) of interest to help make a diagnosis. CAUTION: The law restricts these devices to sale by or on the order of a physician. The patient will be asked to lie on their back or stomach, and should plan to be in the machine for at least 45 minutes in order to complete the exam. Data on file. Whether youre a current employee or looking to refer a patient, we have the tools and resources you need to help you care for patients effectively and efficiently. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Disposable devices intended to assist implantation may be included. Do not expose the delivery system to organic solvents, e.g., alcohol. 2023 Boston Scientific Corporation or its affiliates. The NC Emerge PTCA Dilatation Catheter is contraindicated for use in: PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA as treatment of this patient population carries special risk. Allergic/anaphylactic reaction; Amputation; Aneurysm; Arteriovenous fistula; Death related/unrelated to procedure; Dissection; Embolization; Extravasation; Fever; Hemorrhage/bleeding requiring a blood transfusion; Hematoma; Hypotension/hypertension; Incorrect positioning of the stent requiring further stenting or surgery; Intimal injury/dissection; Ischemia/infarction of tissue/organ; Local infection; Malposition (failure to deliver the stent to the intended site); Open surgical repair; Pain; Pulmonary embolism; Pseudoaneurysm; Renal failure; Respiratory arrest; Restenosis; Rupture; Septicemia/bacteremia; Stent Fracture; Stent Migration; Vasospasm; Venous occlusion/thrombosis/restenosis. arrhythmia, including ventricular fibrillation, coronary vessel dissection, perforation, rupture or injury, possibly requiring surgical repair or intervention, drug reactions, including allergic reaction to contrast medium, total occlusion of the coronary artery or bypass graft, vessel trauma requiring surgical repair or intervention, See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. Unlike other imaging options, MRI displays details of tissue such as tendons, nerves, muscle, and organs. Upon arrival, patients are asked to complete an MR Environment Screening form and an MRI Contrast History form if the exam involves contrast. PDF VICI VENOUS STENT System Instructions for Use - Food and Drug endstream endobj startxref On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. Disposable devices intended to assist implantation may be included. THE List - MRI Safety This test uses a magnetic field, radiofrequency pulses, and a computer to produce detailed images of body structures in multiple planes. ** On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Several of these demonstrated magnetic field interactions. The compatibility of the device has not been evaluated for the delivery of materials (e.g. BD and the BD Logo are trademarks of Becton, Dickinson and Company. There is no preparation necessary for an MRI except for people having an exam called an MRCP, an exam of the gallbladder and the ducts associated with it, or an enterography. Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy. Because the MRI has a powerful magnetic field, patients will be screened and checked to make absolutely sure they dont have any metal objects with them before entering the scan room. NC EMERGE Indications, Safety, and Warnings - Boston Scientific Indications, safety and warnings for the NC Emerge Monorail and Over-the-Wire PTCA Dilatation Catheter. The device is typically intended for long-term, but not permanent, implantation. o. At the 36-month follow-up, the CIVIQ-20 assessment demonstrated a change from baseline in the total study population of -16.8 and, for the VCSS Pain score, a change from baseline in the total population of -1.8. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. This site is Exclusively Sponsored by BRACCO, Hemostatic Clips, Other Clips, Fasteners, and Staples, Orthopedic Implants, Materials, and Devices. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days post-index procedure. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Available in sizes from 1.2 mm to 4.0 mm. for the treatment of iliofemoral venous occlusive disease. We are committed to providing the best experience possible for our patients and visitors. Once in the scan room, the technologist will explain the exam before it begins and will give the patient ear plugs to muffle the noise the machine makes. Data on file, BD Peripheral Intervention, Tempe, AZ. 3Foreshortening is calculated as the difference, represented as percentage, between the compressed stent length and expanded stent length at minimum/maximum oversize (1-3 mm). Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, *6 F guide catheter with a minimum 0.070" ID, 8 F guide catheter with a minimum 0.088" ID, See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Improves overall flexibility and performance in tortuous anatomy, Outer tip material rides over the inner shaft, Designed to improve overall flexibility and tip performance, Short tip designed to lessen tip catch occurrence and offer greater control, Designed for exceptional simultaneous use performance, Reduced frictional force on the catheter shaft, Both stiff and flexible segments to enhance pushability and trackability, One piece outer shaft provides a seamless transition, Designed for less balloon growth and increased rated, Unique blend of balloon materials provides excellent, Provides optimal radiopacity and excellent visibility. BioLinx is a blend of the Medtronic proprietary components C10 and C19, and PVP Kaplan-Meier Primary Patency in Post-Thrombotic Lesions at 36 months, Kaplan-Meier Primary Patency in Non-Thrombotic Lesions at 36 months, Freedom from Target Lesion Revascularization (TLR) at 36 months. 617.638.8000. Boston Medical Center has a long tradition of providing accessible and exceptional care for everyone who comes through our doors. PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. through the guidewire lumen, other than those required for normal use. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. MRI is a more detailed tool than x-ray and ultrasound and for certain organs or areas of the body, it provides better images than CT. In addition, we are devoted to training future generations of health professionals in our wide range of residency and fellowship programs. The ordering physician will go over the findings with their patient. People who are claustrophobic, should consult their physician prior to the day of the appointment for assistance, as the department is not licensed to dispense medication. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 4.8 F Stent Diameter, Device Size Text, specify: 24 cm Effective Length, Device Size Text, specify: 1.6 mm Stent Diameter. This depends on the exam the doctor has ordered. Most people are able to complete the exam easily, but for those who are uncomfortable, there are staff trained to assist them in completing the exam through relaxation and visualization techniques. The Resolute Onyx stent is comprised of a bare metal stent with a Parylene C primer coat and a coating that consists of a blend of the drug zotarolimus and the BioLinx polymer system. *On all models 3.25 mm x 20 mm and 30 mm length balloons 2.75 mm. Data on File. MR Safety and Imaging of Neuroform Stents at 3T Patients who received a Venovo Venous Stent had a weighted PP rate of 88.6%, demonstrating a statistically significant difference from a literature-derived performance goal (PG) of 74%, with an 81.7% PP rate for subjects with post-thrombotic syndrome and 97.1% PP rate for subjects with non-thrombotic iliac vein lesions. Dr. Michael Dake, Senior VP for Health Sciences at the University of Arizona and Principal Investigator in the VenovoVenous Stent VERNACULAR trial shares key findings from the 24-month clinical results including primary patency rates, target lesion revascularization (TLR) and fracture rates, patient quality of life, and more. The C-Code used for EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers MRI measures the water content (or fluid characteristics) of different tissues, which is processed by the computer to create a black and white image. The technologist performing the exam will monitor the patient throughout the scan and they are also able to talk with each other the entire time. Receive Updates. Find products, medical specialty information, and education opportunities. Find out who we are, explore careers at the company, and view our financial performance. For people having an enterography exam, they will be given an oral contrast as well and will need to wait 2 hours after drinking it to allow it to coat their intestines completely. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information AccessGUDID - DEVICE: Ascerta (08714729802976) 2023 Boston Scientific Corporation or its affiliates. The image is highly detailed and can show even the smallest abnormality. PMA Applicant: Boston Scientific Corporation Address: One Scimed Place, Maple Grove, MN 55311-1566 Approval Date: August 11, 2020 Approval Letter: Approval Order What is it? Balloon catheter retrieval methods (use of additional wires, snares, and/or forceps) may result in trauma to the treated vessel and/or the vascular access site. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 2785 0 obj <> endobj A patient with the VICI VENOUS STENT can be scanned safely, immediately after placement, in an MR system meeting the following conditions: o Static magnetic field of 1.5 T or 3.0 T only. EMERGE is a predilatation balloon catheter designed to navigate and cross even the most challenging lesions with ease. 2023 Boston Medical Center. Boston Medical Center (BMC) is a 514-bed academic medical center located in Boston's historic South End, providing medical care for infants, children, teens and adults. Missing x-ray analyses were recorded as protocol deviations. Polaris Ultra Ureteral Stent The device is intended for use by physicians who have received appropriate training. The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established. The average MRI exam takes about 45 minutes. Recorded at the London Charing Cross Symposium in 2019. The C-Code used forNC EMERGE PTCA Dilatation Catheter is C1725 Catheter, Transluminal, Angioplasty, Non-Laser (may include guidance, infusion/perfusion capability). Access our instructions for use and product manuals library. This site is Exclusively Sponsored by BRACCO. Polaris Ultra - BOSTON SCIENTIFIC CORPORATION - In Depth Guide Bench test results may not necessarily be indicative of clinical performance. 44, no. Use only the recommended balloon inflation medium. BD's collection of literature on industry and on our offerings gives you information you can use to continue striving for excellence. 1.5,3: Safe More. The NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters (balloon models 2.00- 5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. Remove the delivery system and replace with a new unit. Prior to stent deployment, remove slack from the delivery system catheter outside the patient. If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol). In addition to this commitment, our robust research and teaching programs keep our hospital on the cutting-edge, while pushing medical care into the future. Find products, medical specialty information, and education opportunities. C-Codes are used for hospital outpatient device reporting for Medicare and some private payers. Brand Name: Polaris Ultra Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729754565 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Ureteral Stent Polaris Ultra - Device Characteristics Polaris Ultra - GMDN MR imaging in patients with Neuroform stent-treated aneurysms is safe and feasible. On all diameters 3.25 mm, on all lengths 15 mm and 3.50 mm x 20 mm. The VERNACULAR study results provide scientific evidence that the Venovo Venous Stent System is safe and effective for the treatment of symptomatic iliofemoral venous Epub 2021 Sep 20. Coronary artery spasm in the absence of a significant stenosis. All other trademarks are the property of their respective owners. To obtain copies images, please call the film library at 617.414.5882. Across all sizes, foreshortening ranged from -4% to 10%, with a mean of 2.9% (values based on mathematical calculations). 0 2023 Boston Scientific Corporation or its affiliates. hUmo0+}B~Dx&~XQT,%DN nU|w{p Broadest size matrix of iliofemoral-indicated venous stents in the U.S. Flared ends designed toreduce stent migrationand maximize wall apposition, Designed for use inhigh compressioniliofemoral venous obstructions, Open-cell,flexible designto conform to vessel curvature while maintaining lumen diameter, Highest mean radial resistive forceamong tested iliofemoral venous stents, Tantalum markers forenhanced visibilityunder fluoroscopy, Minimal foreshortening for maximum lesion coverage, Operator control with an ergonomic handle and dual-speed thumbwheels, Primary safety: Freedom from Major Adverse Events (MAE), including stent migrations, at 30 days, Primary Effectiveness: Primary Patency at 12 months, Venous Clinical Severity Score (VCSS) through 36 months. Once the test has been completed people can return home and resume normal activities. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Bench tests may not be indicative of clinical performance. NC EMERGE PTCA Dilatation Catheter - Boston Scientific Boston Scientific, www.bostonscientific.com . Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures. Testing completed by Boston Scientific Corporation. 1.5 . 2023 Boston Scientific Corporation or its affiliates. One Boston Medical Center Place Testing completed by Boston Scientific Corporation. Coils, Filters, Stents, and Grafts More. Magnetic Resonance Imaging (MRI) | Boston Medical Center AccessGUDID - DEVICE: Tria Soft (08714729959915)

Find: Characters Fnaf World, Sunkara Surname Caste In Andhra Pradesh, Articles B